Smoking CessationNCT05629039
Implementing an Intervention Named Volitional Help Sheets to Reduce Smoking Behaviour Among Young Adults in Indonesia
A study testing Volitional Help Sheets in people with Smoking Cessation, run by University of Manchester at 1 site in United Kingdom.
Trial summary
Indonesia is one of the countries that does not sign The World Health Organization Framework Convention on Tobacco Control (WHO-FCTC), and the numbers of Indonesian smokers increase every year. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Volitional Help Sheets
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,700 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 May 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Smokers whose ages are 20-45 years old
Who cannot join
- Non-smokers whose ages are below 20 years old and above 45 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Volitional Help Sheet to Promote Smoking Cessation Among Young Adults in Indonesia
Indonesia is one of the countries that does not sign The World Health Organization Framework Convention on Tobacco Control (WHO-FCTC), and the numbers of Indonesian smokers increase every year. The Volitional-Help Sheet (VHS) has been used successfully to help people quit smoking, but has not yet been tested in Indonesia. The present study aims to adapt and implement the VHS to promote smoking cessation among smokers aged 20- 45 years. The main outcome measure is smoking abstinence; secondary outcomes are nicotine dependence, and capabilities, opportunities and motivations.
Read the detailed description
The main outcome measure is smoking abstinence; secondary outcomes are nicotine dependence, and capabilities, opportunities and motivations. All participants will be smokers aged 20-45 years who will complete self-report measures of outcomes over three waves of data collection. Once baseline measures are collected, participants will be randomised at wave 1 to intervention versus control condition. Participants in the intervention group will complete the VHS for smoking cessation in addition to the baseline measures. At wave 2, one-month following wave 1, participants will again be randomised to intervention (complete the VHS) and control condition. There will thus be four conditions: control, early intervention, late intervention and repeated intervention. Outcomes will be assessed at wave 3, six-months after wave 2.
- Conditions
- Smoking Cessation
- Being tested
- Volitional Help Sheets
- Keywords
- Volitional help sheets, Young adults, Smoking cessation, Indonesia
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volitional Help SheetsBehavioural
Also called Volitional help sheets for smoking cessation
The volitional help sheet is an intervention which provides an opportunity for people to actively plan their behavioural changes by using a list of situations and solutions. The list of situations are critical situations which provoke unwanted behaviour, and the solutions are the responses to overcome the situations which urge the unexpected behaviour. In the context of smoking behaviour, the list of situations is the situations that will provoke cigarette uptake and the list of solutions is the appropriate responses to reduce or stop the urge to smoke.
| Study group | Role | What they receive |
|---|---|---|
| Wave 1-Experimental Group | Experimental | The experimental group in Wave 1 will complete the baseline questionnaires (the socio-demographic, FTND, and COM-B questionnaires) followed by both the if-then list and the if-then link from the Volitional-Help Sheet as manipulations. The if-then list consists of several situations and solutions linked to smoking uptake in the volitional help sheet and the group will be informed that the activity will help to stop smoking. In addition, the if-then link consists of the situations in which people are urged to smoke and then link them to solutions that are most likely to help them abstain from starting smoking Receives: Behavioral: Volitional Help Sheets |
| Wave 1-Control Group | No intervention | The control group participants will complete the baseline questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire) without further intervention |
| Wave 2-Control group | No intervention | This group will complete the one-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire) without further intervention |
| Wave 2-Delayed VHS Group | Experimental | This group will receive the (delayed) Volitional Help Sheets intervention after completing the one-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire). Receives: Behavioral: Volitional Help Sheets |
| Wave 2-Early VHS Group | Experimental | This group will complete the one-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire) without further intervention Receives: Behavioral: Volitional Help Sheets |
| Wave 2-Repeated VHS group | Experimental | This group will complete the one-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire), and receive a repeated, booster VHS intervention. Receives: Behavioral: Volitional Help Sheets |
| Wave 3-Control Group | No intervention | This group will complete the six-month follow-up questionnaires. Due to ethical consideration, in wave three the control group will be offered the opportunity to complete the VHS form after they complete the follow-up assessments and the scores will not be included in the analysis. |
| Wave 3-Delayed VHS Group | Experimental | This group will complete the six-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire) without further intervention Receives: Behavioral: Volitional Help Sheets |
| Wave 3-Early VHS Group | Experimental | This group will complete the six-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire) without further intervention Receives: Behavioral: Volitional Help Sheets |
| Wave 3-Repeated VHS Group | Experimental | This group will complete the six-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire) without further intervention Receives: Behavioral: Volitional Help Sheets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Cessation
Participants will complete a self-report questionnaire to assess their cigarette uptake by ticking one of the following options: (a) I have never smoked (b) I have only tried smoking once (c) I used to smoke sometimes, but I never smoke cigarettes now (d) I sometimes smoke cigarettes now, but I do not smoke as many as one a week (e) I usually smoke between one and six cigarettes a week (f) I usually smoke more than six cigarettes a week. The code for the response of options "a-d" is 0, and "e-f" is 1.
Measured: 6 months
Secondary outcomes (2)
Nicotine dependence
The Fagerstrom nicotine dependence scale will assess nicotine dependence. The scoring method in FTND is 0 to 1 for yes/no items and a score of 0 to 3 for the multiple-choice items. The items are summed to yield a total score of 0-10. The higher the total FTND score, the more intense the smoker's physical dependence on nicotine.
Measured: 6 months
Intervention evaluation
The Capability Opportunity Motivation-Behaviour (COM-B) Questionnaire will measure how the intervention contributes to the behaviour changes. The higher the score, the more the intervention contributes to the behaviour changes.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start15 May 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 2,700 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rina Rahmatika, University of Manchester
- Investigators
- Christopher Armitage, Principal investigator, University of ManchesterTim Millar, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629039
- Sponsor's protocol ID
- VHS-Indonesia
- Status last verified
- Apr 2026
- First submitted
- 22 Sep 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research team will receive anonymous data from the survey panel company. Therefore, there will be no identifiable data to be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volitional Help Sheet to Promote Smoking Cessation Among Young Adults in Indonesia
- ClinicalTrials.gov ID
- NCT05629039
- Acronym / sponsor ID
- VHS-Indonesia
- Conditions
- Smoking Cessation
- Keywords
- Volitional help sheets, Young adults, Smoking cessation, Indonesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,700 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Indonesia is one of the countries that does not sign The World Health Organization Framework Convention on Tobacco Control (WHO-FCTC), and the numbers of Indonesian smokers increase every year. The Volitional-Help Sheet (VHS) has been used successfully to help people quit smoking, but has not yet been tested in Indonesia. The present study aims to adapt and implement the VHS to promote smoking cessation among smokers aged 20- 45 years. The main outcome measure is smoking abstinence; secondary outcomes are nicotine dependence, and capabilities, opportunities and motivations.
Detailed description
The main outcome measure is smoking abstinence; secondary outcomes are nicotine dependence, and capabilities, opportunities and motivations. All participants will be smokers aged 20-45 years who will complete self-report measures of outcomes over three waves of data collection. Once baseline measures are collected, participants will be randomised at wave 1 to intervention versus control condition. Participants in the intervention group will complete the VHS for smoking cessation in addition to the baseline measures. At wave 2, one-month following wave 1, participants will again be randomised to intervention (complete the VHS) and control condition. There will thus be four conditions: control, early intervention, late intervention and repeated intervention. Outcomes will be assessed at wave 3, six-months after wave 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Wave 1-Experimental Group | Experimental | Behavioral: Volitional Help SheetsThe experimental group in Wave 1 will complete the baseline questionnaires (the socio-demographic, FTND, and COM-B questionnaires) followed by both the if-then list and the if-then link from the Volitional-Help Sheet as manipulations. The if-then list consists of several situations and solutions linked to smoking uptake in the volitional help sheet and the group will be informed that the activity will help to stop smoking. In addition, the if-then link consists of the situations in which people are urged to smoke and then link them to solutions that are most likely to help them abstain from starting smoking |
| Wave 1-Control Group | No intervention | –The control group participants will complete the baseline questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire) without further intervention |
| Wave 2-Control group | No intervention | –This group will complete the one-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire) without further intervention |
| Wave 2-Delayed VHS Group | Experimental | Behavioral: Volitional Help SheetsThis group will receive the (delayed) Volitional Help Sheets intervention after completing the one-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire). |
| Wave 2-Early VHS Group | Experimental | Behavioral: Volitional Help SheetsThis group will complete the one-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire) without further intervention |
| Wave 2-Repeated VHS group | Experimental | Behavioral: Volitional Help SheetsThis group will complete the one-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire), and receive a repeated, booster VHS intervention. |
| Wave 3-Control Group | No intervention | –This group will complete the six-month follow-up questionnaires. Due to ethical consideration, in wave three the control group will be offered the opportunity to complete the VHS form after they complete the follow-up assessments and the scores will not be included in the analysis. |
| Wave 3-Delayed VHS Group | Experimental | Behavioral: Volitional Help SheetsThis group will complete the six-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire) without further intervention |
| Wave 3-Early VHS Group | Experimental | Behavioral: Volitional Help SheetsThis group will complete the six-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire) without further intervention |
| Wave 3-Repeated VHS Group | Experimental | Behavioral: Volitional Help SheetsThis group will complete the six-month follow-up questionnaires (the socio-demographic questionnaire, the FTND, and the COM-B Questionnaire) without further intervention |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Smokers whose ages are 20-45 years old
Key exclusion criteria (1 listed)
- Non-smokers whose ages are below 20 years old and above 45 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volitional Help SheetsAlso: Volitional help sheets for smoking cessationThe volitional help sheet is an intervention which provides an opportunity for people to actively plan their behavioural changes by using a list of situations and solutions. The list of situations are critical situations which provoke unwanted behaviour, and the solutions are the responses to overcome the situations which urge the unexpected behaviour. In the context of smoking behaviour, the list of situations is the situations that will provoke cigarette uptake and the list of solutions is the appropriate responses to reduce or stop the urge to smoke. | Behavioural | Wave 1-Experimental Group, Wave 2-Delayed VHS Group, Wave 2-Early VHS Group, Wave 2-Repeated VHS group, Wave 3-Delayed VHS Group, Wave 3-Early VHS Group, Wave 3-Repeated VHS Group |
Primary outcome
Smoking Cessation
Time frame: 6 months
Participants will complete a self-report questionnaire to assess their cigarette uptake by ticking one of the following options: (a) I have never smoked (b) I have only tried smoking once (c) I used to smoke sometimes, but I never smoke cigarettes now (d) I sometimes smoke cigarettes now, but I do not smoke as many as one a week (e) I usually smoke between one and six cigarettes a week (f) I usually smoke more than six cigarettes a week. The code for the response of options "a-d" is 0, and "e-f" is 1.
2 secondary outcomes
Nicotine dependence
Time frame: 6 months
Intervention evaluation
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No. The research team will receive anonymous data from the survey panel company. Therefore, there will be no identifiable data to be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Armitage principal investigator
University of Manchester
Tim Millar principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volitional Help Sheets in people with Smoking Cessation, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Cessation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.